Ignite Creation Date:
2024-05-05 @ 10:37 PM
Last Modification Date:
2024-10-26 @ 10:21 AM
Study NCT ID:
NCT01142245
Status:
COMPLETED
Last Update Posted:
2015-08-13
First Post:
2010-06-09
Brief Title:
Effect of IV and Oral Esomeprazole in Prevention of Recurrent Bleeding From Peptic Ulcers After Endoscopic Therapy
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Phase 3 Study of Effect of Intravenous and Oral Esomeprazole in Prevention of Recurrent Bleeding From Peptic Ulcers After Endoscopic Therapy IOE Study
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IOE
Brief Summary:
The investigators previously showed that the use of a high-dose intravenous PPI regimen after endoscopic control of bleeding from peptic ulcers reduced rate of recurrent bleeding decreased the need for endoscopic and surgical interventions and in general improved patients outcomes A trend towards reduced mortality associated with the use of high-dose intravenous PPI was also observed Recent clinical trials from Asia have provided evidence that high-dose oral PPIs are associated with a reduction in rebleeding Current meta-analysis suggests that both high dose intravenous and low dose oral PPIs effectively reduce rebleeding vs placebo However there has been no clinical study to compare IV infusion to oral PPI in this patient population
The purpose of this clinical study is to compare the efficacy and safety of intravenous and oral Esomeprazole in patients with peptic ulcer hemorrhage who are at risk for recurrent bleeding The investigators hypothesize that using IV infusion is superior to oral PPI
The purpose of this clinical study is to compare the efficacy and safety of intravenous and oral Esomeprazole in patients with peptic ulcer hemorrhage who are at risk for recurrent bleeding The investigators hypothesize that using IV infusion is superior to oral PPI
Detailed Description:
The investigators previously showed that the use of a high-dose intravenous PPI regimen after endoscopic control of bleeding from peptic ulcers reduced rate of recurrent bleeding decreased the need for endoscopic and surgical interventions and in general improved patients outcomes A trend towards reduced mortality associated with the use of high-dose intravenous PPI was also observed Recent clinical trials from Asia have provided evidence that high-dose oral PPIs are associated with a reduction in rebleeding Current meta-analysis suggests that both high dose intravenous and low dose oral PPIs effectively reduce rebleeding vs placebo However there has been no clinical study to compare IV infusion to oral PPI in this patient population
Endoscopic stigmata in bleeding peptic ulcers are prognostic and allow risk stratification Patients with a clean ulcer base have a 5 risk of rebleeding this increases progressively with a flat spot adherent clot non-bleeding visible vessel and active bleeding 55 Early endoscopy in patients with bleeding peptic ulcers selects the high risk ulcers for therapy and evaluation of adjuvant PPI use
Endoscopic stigmata in bleeding peptic ulcers are prognostic and allow risk stratification Patients with a clean ulcer base have a 5 risk of rebleeding this increases progressively with a flat spot adherent clot non-bleeding visible vessel and active bleeding 55 Early endoscopy in patients with bleeding peptic ulcers selects the high risk ulcers for therapy and evaluation of adjuvant PPI use
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None